# K170845: MiniMAX

- Pathway: 510(k) (Traditional)
- Applicant: Medacta International S.A.
- Decided: Aug 8, 2017 after 140 days
- Product code: LZO (Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3353
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K921308 (1994). 24 ancestors in all.
7 later devices descend from it; 4 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123604: Abg Iii Monolithic Hip Stem, Howmedica Osteonics Corp. (2013) Summary page 4.
- K151531: MasterLoc Stem, Medacta International (2015) Summary page 4.

## Most influential descendants
- K181693: SMS Femoral Stem (2018), 4 descendants of its own
- K201673: SMS Cementless Stem (2020), 3 descendants of its own
- K192352: MiniMAX (2019), 2 descendants of its own
- K203041: SMS Cementless Stem (2020), 1 descendant of its own
- K250450: Coated hip implants (2025), 0 descendants of its own

## Recalls of this device
- Nov 15, 2017 · Class II · Z-0196-2019: Complaint monitoring noted a trend of packaging being breached for the MiniMAX Stem.

## Indications for use
The hip prosthesis MiniMAX is designed for cementless use in total or partial hip arthroplasty in primary or revision surgery. Hip Replacement is indicated in the following cases: • Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid polyarthritis, or congenital hip dysplasia. • Avascular necrosis of the femoral head. • Acute traumatic fracture of the femoral head or neck. • Failure of previous hip surgery: joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.

Source page: https://510kreport.com/device/K170845
Methodology: https://510kreport.com/methodology